FDA to Review Osteoporosis Drug Use

Osteoporosis Vitamins

FDA to Review Osteoporosis Drug Use

FDA to Review Osteoporosis Drug Use

Concerns over use of osteoporosis bone drugs containing bisphosphonate have led to an upcoming review by the FDA. This Friday, an advisory committee will meet to debate the risk associated with long-term use of drugs, such as Fosamax, Boniva, and Reclast, due to evidence that serious side effects, such as jawbone deterioration and atypical breaks occur when the prescription medications are used for an extended period of time.

Bisphosphonates can increase mass to deteriorating bones and reduces the risk of future breaks caused by aging, estrogen deficiency and corticosteroid use. Oral bisphosphonates are typically prescribed for female patients with osteoporosis. The condition causes bones to become more porous, meaning less solid and less dense. This gradually leads to bones becoming weaker and more brittle, leading to breaks. About 80 percent of people affected by osteoporosis are women. In addition, 80 percent of women over the age 65 have the disease.

Bisphosphonates started carrying warnings on the risk of jawbone deterioration (called osteonecrosis) in 2005. While data is still incomplete on the cause of the deterioration, studies have shown that patients who take an oral form of bisphosphonates have a higher prevalence of the condition, particularly after having been on a daily regimen for four or more years.
Additional warnings, added in 2010, were required due to reporting of an increase—albeit small—in atypical bone breaks in women who had long-term use of bisphosphonates. According to a review released last week by the FDA, atypical breaks appear to have a strong association with bisphosphonates, but there is no consensus on the extent that cumulative use of bisphosphonates increases the risk of atypical breaks.

The committee will be discussing the benefits of taking a “drug holiday.” Studies have shown that women who take the drug for three years and then stop have the same break rate as those who continue taking the drug for longer periods of time.

An Australian study, published in February of this year, found that certain osteoporosis treatments can increase lifespan by five years. In addition, the findings held right whether or not a person suffered from the bone-density disorder. According to the Australian researchers from the Garvan Institute of Medical Research, people taking bisphosphonates for the treatment of osteoporosis were found to have a higher survival rate, and were really gaining an additional five years of life.